Principal Scientist, Early DCT Lead

MSD•Rahway, NJ

About The Position

This high-visibility role combines integrated cross-functional program leadership with deep subject-matter expertise in biologics analytical development. As an Early-Stage Development and Commercialization Team (DCT) Lead, the role provides strategic, technical, and operational direction for integrated CMC teams, advancing pipeline biologics from candidate selection through early clinical development and First-in-Human milestones while laying the groundwork for commercialization. The position is also an analytical subject-matter expert within the department, guiding method development, phase-appropriate integrated analytical control strategies, Critical Quality Attribute (CQA) assessment, and robust characterization to support high-quality pipeline progression. The role leads assigned programs across formal governance gates, aligns matrixed CMC functions and external partners, manages program risks, and communicates recommendations to senior leadership and governance bodies. Its analytical responsibilities include defining control strategies and characterization workflows, evaluating CQAs and degradation pathways, supporting regulatory filings and health-authority responses, and troubleshooting complex analytical and formulation or downstream-processing challenges. The position also mentors scientists and project members and advances continuous improvement, inclusive leadership, and operational excellence. The position is based primarily in Rahway, New Jersey. Domestic or international relocation is available, visa sponsorship is offered, travel is 10%, and flexible work arrangements are listed as not applicable. The role is regular status. The salary range for the primary location is $156,900–$247,000, and the successful candidate is eligible for an annual bonus and long-term incentive, if applicable. Benefits include medical, dental, vision and other insurance, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.

Requirements

Ph.D. in Analytical Chemistry, Biochemistry, Chemical/Biochemical Engineering, Biophysics, or a related scientific discipline and at least 8 years of relevant biopharmaceutical industry experience; or an M.S. in a related scientific discipline and at least 10 years; or a B.S. in a related scientific discipline and at least 14 years.
Demonstrated experience as a DCT lead or in an equivalent cross-functional program leadership role, driving execution across drug substance, drug product, analytical, regulatory, quality, device/packaging, manufacturing, and supply chain functions.
Proven biologics analytical development experience, including method design, qualification or validation, method transfer, phase-appropriate specification setting, and identification of CQAs and degradation pathways.
Demonstrated analytical-sciences and biologics-development leadership through active engagement with external consortia, scientific conferences, and/or peer-reviewed publications.
Subject-matter expertise with modern biophysical and biochemical analytical platforms, including relevant separation sciences, mass spectrometry, biophysical techniques, functional or potency assays, and/or process-related residuals.
Direct experience authoring, reviewing, and defending analytical and CMC sections of regulatory filings (IND, IMPD, or equivalent), health-authority briefing packages, and information requests.
Ability to identify program risks, clarify cross-functional trade-offs, establish contingency pathways, and guide data- and judgment-based decisions.
Exceptional collaboration, facilitation, and influencing skills in matrix environments without direct authority.
Ability to synthesize complex technical data into concise, decision-oriented communications for governance and executive leadership.
Demonstrated accountability for program delivery and milestone execution.
Commitment to mentoring junior scientists and fostering an inclusive, transparent, high-trust team culture.

Nice To Haves

Experience with accelerated development paradigms, platform strategies, or transition from early-stage development to late-stage commercialization readiness.
Experience with complex biological modalities such as bispecific or multispecific antibodies, antibody-drug conjugates (ADCs), or fusion proteins.

Responsibilities

Lead assigned pipeline biologics as an Early-Stage Development and Commercialization Team (DCT) Lead, with accountability for integrated CMC strategy, milestone readiness, cross-functional alignment, and progression through governance gates.
Establish and operationalize matrixed CMC project teams, working groups, decision rights, timelines, escalation pathways, and clear accountability.
Align Drug Substance, Drug Product, Analytical Development, Regulatory Affairs, Quality Assurance, Global Supply Chain, Pilot Plant/Commercial Manufacturing, and external partner organizations.
Identify program vulnerabilities, assess cross-functional trade-offs, develop data-driven contingency plans, and communicate recommendations to leadership, governance bodies, and stakeholders.
Drive disciplined project execution through meeting cadences, decision logs, action tracking, risk registers, and timely communication.
Define phase-appropriate analytical control strategies, product characterization workflows, and specification-setting rationales for early-phase biological modalities.
Oversee CQA evaluation, forced-degradation and structure-function studies, and in-use stability and compatibility work to support comparability and shelf-life decisions.
Guide and contribute to authoring, reviewing, and approving analytical sections of IND/IMPD filings, briefing books, and responses to health-authority queries.
Lead or actively participate in Analytical Technical Reviews (ATRs).
Troubleshoot complex analytical, formulation, and downstream-processing challenges using advanced physicochemical, biophysical, and functional characterization expertise.
Mentor and coach early-career scientists, functional leads, and technical project members.
Champion initiatives to accelerate First-in-Human cycle times, streamline CMC governance handoffs, and adopt innovative analytical or digital/informatics workflows.
Model inclusive leadership, psychological safety, transparent communication, and operational excellence across matrix teams and departmental functions.